Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT02809768
Eligibility Criteria:
Inclusion Criteria:
1. Platelet count between the lower limit of normal and 300 × 10\^9/L, inclusive, at Screening and each Baseline.
2. Non-smoking, male or female, age ≥18 years and ≤55 years old.
3. Body mass index (BMI) \>18 and ≤32 kg/m\^2 at Screening.
4. Females must not be pregnant at Screening as documented by a negative serum beta human chorionic gonadotropin (β-hCG) test with a minimum sensitivity 25 IU/L or equivalent units of β-hCG or at Baseline as documented by a negative urine pregnancy test result.
Exclusion Criteria:
1. Failure to discontinue use of agents associated with higher risk of thrombosis (including estrogen containing oral contraceptives) within at least 30 days before dosing.
2. Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history (e.g., history of splenectomy); history of arterial or venous thrombosis, including partial or complete thromboses (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism); known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency).
3. Hemoglobin less than lower limit of normal at Screening and Baseline Period 1.
4. Liver functions tests (alanine transaminase \[ALT\], aspartate transaminase \[AST\], or total bilirubin) greater than the upper limit of normal Screening and Baseline Period 1.
5. Any history of gastrointestinal surgery that may affect the pharmacokinetics (PK) profiles of avatrombopag (e.g., hepatectomy, nephrectomy, cholecystectomy or digestive organ resection) at Screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02809768
Study Brief:
Protocol Section:
NCT02809768